- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06106022
A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease
April 3, 2024 updated by: Phathom Pharmaceuticals, Inc.
A Phase 1, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan (10 or 20 mg Once Daily) in Children Aged ≥ 6 to < 12 Years Who Have Symptomatic Gastroesophageal Reflux Disease
The aim of this study is to evaluate the pharmacokinetic (PK) profile of vonoprazan (10 or 20 mg once daily [QD]) in children ≥ 6 to < 12 years of age who have symptomatic Gastroesophageal Reflux Disease (GERD).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Phathom Medical Information
- Phone Number: 1-888-775-7248
- Email: medicalinformation@phathompharma.com
Study Locations
-
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Alabama
-
Mobile, Alabama, United States, 36604
- Recruiting
- Strada Patient Care Center
-
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Arkansas
-
Little Rock, Arkansas, United States, 72211
- Recruiting
- Preferred Research Partners, Inc.
-
-
Florida
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Hollywood, Florida, United States, 33024
- Recruiting
- Med Research Associates, Inc
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Pensacola, Florida, United States, 32503
- Recruiting
- Avanza Medical Research Center
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Tampa, Florida, United States, 33614
- Recruiting
- International Center for Research
-
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Georgia
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Atlanta, Georgia, United States, 30342
- Recruiting
- Children's Center for Digestive Health Care, LLC
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Indiana
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Indianapolis, Indiana, United States, 46202
- Recruiting
- Riley Hospital for Children at IU Health
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Louisiana
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Marrero, Louisiana, United States, 70072
- Recruiting
- Tandem Clinical Research GI, LLC
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-
New York
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Bronx, New York, United States, 10467
- Recruiting
- Advantage Clinical Trials
-
-
Ohio
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Dayton, Ohio, United States, 45429
- Recruiting
- PriMed Clinical Research
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Oregon
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Gresham, Oregon, United States, 97030
- Recruiting
- Cyn3rgy Research
-
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Texas
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El Paso, Texas, United States, 79902
- Recruiting
- Maspons Pediatric Gastro
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Frisco, Texas, United States, 75033
- Recruiting
- Stryde Research - NxT Step Pediatrics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The participant has a body weight within the 5th through 95th percentile by age, inclusive, as determined by the National Center for Health Statistics.
- The participant must have a diagnosis of GERD prior to randomization and medical history of signs or symptoms of GERD for at least 3 months prior to screening, based on physical examination, current symptoms (eg, heartburn), or diagnostic tests (eg, pH or endoscopy). Notes in the medical records and/or other source documents, such as prior endoscopies, can be used to support the diagnosis and will be recorded in the electronic case report form (eCRF).
- The participant has at least one moderate GERD symptom based on the GERD Symptom Assessment-Investigator scale performed at screening.
- The participant must be able to swallow study drug tablet with water.
- Parent or legal guardian (ie, legally authorized representative [LAR]) is willing and able to complete the informed consent process and participants are able to comply with study procedures and visit schedule.
- Female participants who have experienced menarche must have a negative pregnancy test and will be counseled on pregnancy avoidance.
Exclusion Criteria:
- The participant has used prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonist (H2RAs) within 7 days prior to randomization or requires use during the Treatment Period.
- The participant has used sucralfate, or antacids within 1 day prior to randomization or requires their use during the Treatment Period.
- The participant has received other agents affecting digestive organs, including muscarinic antagonists (eg, hyoscyamine), prokinetics, oral anticholinergic agents, prostaglandins, bismuth from 30 days prior to Day 1 or requires their use during the course of the study.
- The participant has received atazanavir sulfate or rilpivirine hydrochloride from 5 days prior to Day 1 or requires their use during the course of the study.
- The participant has received any investigational compound (including vonoprazan) within 30 days prior to the start of the Screening Period.
- The participant is an immediate family member or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, child, sibling) or participant may have consented under duress.
- The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Period.
- The participant has undergone prior gastrointestinal surgeries.
- The participant has any abnormal laboratory test values that are considered clinically significant in the opinion of the investigator during the Screening Period.
- The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropylcellulose, fumaric acid, ascorbic acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, and titanium dioxide, or red or yellow ferric oxide).
- The participant has used any prescription or over-the-counter medications (including herbal or nutritional supplements), other than those already excluded in criteria 1 to 5 above, within 14 days before the first dose of study drug or throughout the study. That is, unless the medication(s) is permitted by the sponsor following a review of available data which confirms concomitant administration of the medication is unlikely to affect either the safety of the participant or the pharmacokinetics of vonoprazan.
- The participant has consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or other food products that may be CYP3A4 inhibitors (eg, vegetables from the mustard green family [kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard] and charbroiled meats) within 7 days (or 5 half-lives) before the first dose of study drug or throughout the study.
- The participant has positive results at screening for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus (HCV).
- The participant has severe renal impairment (estimated glomerular filtration rate < 30 mL/min).
- The participant has moderate to severe hepatic impairment (Child-Pugh Class B and Child-Pugh Class C).
The participant has any of the following abnormal laboratory test values at the start of the Screening Period:
- Creatinine levels: >1 mg/dL (>88 μmol/L ).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except participants with Gilbert Syndrome).
- In the opinion of the investigator, the participant is not suitable for entry into the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vonoprazan 10mg
Participants will receive vonoprazan 10mg QD for 14 days.
|
Administered orally
|
Experimental: Vonoprazan 20mg
Participants will receive vonoprazan 20mg QD for 14 days.
|
Administered orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Drug Concentration at Steady-state (Cmax,ss) of Vonoprazan
Time Frame: Days 7 and 14
|
Days 7 and 14
|
Area Under the Drug Concentration-time Curve (AUCτ) of Vonoprazan
Time Frame: Days 7 and 14
|
Days 7 and 14
|
Apparent Plasma Clearance (CL/F) of Vonoprazan
Time Frame: Days 7 and 14
|
Days 7 and 14
|
Apparent Volume of Distribution (Vz/F) of Vonoprazan
Time Frame: Days 7 and 14
|
Days 7 and 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
October 24, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
April 3, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VPED-103
- 2022-003228-42 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroesophageal Reflux Disease
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TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
-
Mansoura UniversityWithdrawnGastroesophageal Reflux Disease
-
Cliniques universitaires Saint-Luc- Université...UnknownGastroesophageal Reflux DiseaseBelgium
-
King Chulalongkorn Memorial HospitalCompleted
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
PfizerTerminatedGastroesophageal Reflux DiseaseBrazil, Germany, Korea, Republic of, Belgium, Spain, Slovakia, France
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux Disease (GERD) | RefluxUnited States, Canada
Clinical Trials on Vonoprazan
-
TakedaCompleted
-
Phathom Pharmaceuticals, Inc.Completed
-
Phathom Pharmaceuticals, Inc.CompletedGastroesophageal RefluxUnited States
-
Phathom Pharmaceuticals, Inc.CompletedHeartburn | Non-Erosive Gastro-Esophageal Reflux DiseaseUnited States
-
Phathom Pharmaceuticals, Inc.CompletedHeartburn | Non-Erosive Gastro-Esophageal Reflux DiseaseUnited States
-
TakedaCompleted
-
TakedaCompletedGastric Ulcer, Duodenal Ulcer, and Reflux EsophagitisJapan
-
Nanjing First Hospital, Nanjing Medical UniversityNot yet recruitingHelicobacter Pylori InfectionChina
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityCompletedHelicobacter Pylori Eradication RateChina
-
Xijing Hospital of Digestive DiseasesRecruitingthe Eradication Rates of Helicobacter PyloriChina